BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 2142629 · Received June 21, 2011

    Report

    Report Number
    1824206-2011-03362
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    HILL-ROM INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SUPPORT INSTRUCTED THE BIOMED TO REPLACE THE CASTER. THE ACCOUNT HAS NOT RETURNED HILL-ROM'S ATTEMPTS TO DETERMINE THE RESOLUTION OF THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    THE BIOMED STATED THE LEFT FOOT CASTER WILL NOT COME OUT OF BRAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY BED BIRTHING BED HDD HILL-ROM INC. 3600

    Patients

    Seq Age Sex Outcome Treatment
    1